FDA admonishes Bayer
on unproven health claims

WASHINGTON - Aspirin medicines from Bayer designed to promote healthy hearts and stronger bones are being marketed illegally with unproven health claims, federal regulators said Tuesday.

The Food and Drug Administration scolded the company in two warning letters for never submitting proof that its pills - Bayer Women's Low Dose Aspirin + Calcium and Bayer Aspirin with Health Advantage - are effective in battling heart disease and osteoporosis.

Treatments for those diseases must be reviewed by government scientists and cannot be sold over-the-counter, the FDA said. Doctors recommend aspirin to treat aches and pains and as a blood thinner for patients with heart disease.

"The FDA will take enforcement action against manufacturers found to be violating the law or attempting to circumvent the drug approval process," said Mike Chappell, an FDA associate commissioner.

No major negative reactions have been reported with Bayer's drugs, according to the FDA.

German conglomerate Bayer said it stands behind the claims on both products, adding that they are not intended to replace professional medical advice.

"All of our communication on product benefits prominently features information for consumers to check with their physicians to determine if the product is right for them," the company said in a statement. Bayer said it would respond to the FDA letters in the next 15 business days, as requested by regulators.